510(k) Report

Devices descending from K023675

482 later devices reach Synthes Cervifix/ Axon through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+4K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+4K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+4K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+4K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+4K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+4K133698Synapse SystemSynthes USA Products, LLC20146—
+4K132878M.U.S.T. ExtensionMedacta International201328—
+4K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+4K122163Certex Spinal Implant SystemX-Spine Systems, Inc.20122—
+4K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+4K120467Spinal Elements Posterior Cervical/Thoracic Spinal SystemSpinal Elements, Inc.20121—
+4K121808Casian, 3.5/4.5 ConnectorsK2m, Inc.20121—
+4K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+4K120656Everest Spinal SystemK2m, Inc.201243—
+4K113346Neon SystemUlrich GmbH & Co. KG20121—
+4K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+4K072729SierraSeaspine, Inc.20085—
+4K080526Sierra SystemSeaspine, Inc.20089—
+5K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+5K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+5K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+5K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+5K232167VySpan™ PCT SystemVy Spine, LLC20230—
+5K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+5K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+5K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+5K230614Cortium™Ulrich Medical USA20230—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+5K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K222698CUVIS-spineCurexo, Inc.20220—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+5K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+5K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+5K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K183381Navigation Enabled InstrumentsStryker20191—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+5K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+5K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+5K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+5K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+5K180433Ennovate®Aesculap Implant Systems, LLC201811
+5K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+5K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+5K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+5K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+5K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+5K162575Z-LINKPC SystemZavation, LLC20173—
+5K161149PASS OCT Spinal SystemMedicrea International SA20160—
+5K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+5K160428Certex Spinal Fixation SystemX-Spine Systems, Inc.20160—
+5K160756PASS OCT Spinal SystemMedicrea International SA20160—
+5K153169PASS OCT Patient Specific RodsMedicrea International20164—
+5K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+5K131833Centurion Poct SystemOrthofix, Inc.20142—
+5K133094Certex Oct Spinal Implant SystemX-Spine Systems, Inc.20131—
+5K132757Everest Spinal SystemK2m, Inc.201341—
+5K131427LOTUSSpinal Elements, Inc.20130—